Data Foundry

Medical device recalls 2018

ReNew Dolphin Nose Disposable Dissector Tip — Class II medical device recall Z-1740-2018

Terminated recall by Microline Surgical, Inc., reported 2018-05-16, distributed in FL, MA, MI, OH, OK, TN. Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.

Recall numberZ-1740-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMicroline Surgical, Inc., Beverly, MA, United States
Recall initiated2017-11-01
Classified2018-05-08
Reported by FDA2018-05-16
Terminated2019-09-17
DistributedFL, MA, MI, OH, OK, TN
Countries outside the USNL
Reason classessterility
UPC / GTIN / UDI-DI00811099011989
Lot numbers70208, 70209, 70210
Model numbers3312

Product

ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

Reason for recall

Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1740-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.